To investigate the efficacy and safety of high-dose vitamin D supplementation (VDS) plus standard urotherapy (SU) in managing overactive bladder dry (OAB-dry) in children.
A 3-arm, randomized clinical trial was performed at an academic center in China between January 2023 to June 2023. Eligible patients (n=303) were randomized to receive 8 weeks of: high-dose VDS (vitamin D3 drops encapsulated as soft capsules, 2400 IU/d) plus SU (VDS+SU group) (n=100), solifenacin (5-10 mg/d) plus SU (SOL+SU group) (n=102); or SU alone (SU group) (n=101). Reduction in voiding frequency was the primary outcome. Secondary outcomes encompassed improvement in urgency, nocturia, quality of life (QoL) score, pediatric lower urinary tract symptom (PLUTS) score, and participant satisfaction. Treatment-emergent adverse events (TEAEs) were recorded within each group.
Participants had a median age of 82.0 months and their baseline mean vitamin D level was 22.64 ng/mL. The VDS+SU group showed greater improvements in voids/d than the SOL+SU group (median difference 3.0; 95% CI 2.0 to 3.5; P < .001) and the SU group (median difference 4.0; 95% CI 3.0 to 5.0; P < .001) after intervention. The VDS+SU group also showed the greatest improvement in QoL and PLUTS scores. Patient satisfaction was similar between the SOL+SU and SU groups. The VDS+SU group did not exhibit a heightened risk of TEAEs compared to the other groups.
High-dose VDS plus SU was effective and well-tolerated in managing OAB-dry in children, suggesting its potential as a novel therapeutic option for this population.
The Journal of urology. 2023 Oct 23 [Epub ahead of print]
Hongsong Chen, Zhicheng Zhang, Shengde Wu, Deying Zhang, Xiaoni Zhong, Xing Liu, Guanghui Wei
Department of Urology, Children's Hospital of Chongqing Medical University, Chongqing, PR China., Chongqing Medical University, Chongqing, PR China.